AHA bleeding related to warfarin and dabigatran 2013 khotailieu y hoc

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Management and Outcomes of Major Bleeding during Treatment with Dabigatran or Warfarin Ammar Majeed, Hun-Gyu Hwang, Stuart J Connolly, John W Eikelboom, Michael D Ezekowitz, Lars Wallentin, Martina Brueckmann, Mandy Fraessdorf, Salim Yusuf and Sam Schulman Circulation published online September 30, 2013; Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2013 American Heart Association, Inc All rights reserved Print ISSN: 0009-7322 Online ISSN: 1524-4539 The online version of this article, along with updated information and services, is located on the World Wide Web at: http://circ.ahajournals.org/content/early/2013/09/30/CIRCULATIONAHA.113.002332 Data Supplement (unedited) at: http://circ.ahajournals.org/content/suppl/2013/09/30/CIRCULATIONAHA.113.002332.DC1.html Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in Circulation can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office Once the online version of the published article for which permission is being requested is located, click Request Permissions in the middle column of the Web page under Services Further information about this process is available in the Permissions and Rights Question and Answer document Reprints: Information about reprints can be found online at: http://www.lww.com/reprints Subscriptions: Information about subscribing to Circulation is online at: http://circ.ahajournals.org//subscriptions/ Downloaded from http://circ.ahajournals.org/ by guest on April 27, 2014 DOI: 10.1161/CIRCULATIONAHA.113.002332 Management and Outcomes of Major Bleeding during Treatment with Dabigatran or Warfarin Running title: Majeed et al.; Dabigatran and major bleeding Ammar Majeed, MD1; Hun-Gyu Hwang, MD2; Stuart J Connolly, MD3; John W Eikelboom, MD3; Michael D Ezekowitz, MD, ChB, Dphil4; Lars Wallentin, MD5; PhD, Martina Brueckmann, MD6,7; Mandy Fraessdorf, PhD6; Salim Yusuf, MD, Dphil3; Sam Schulman, MD, PhD1,8 Coagulation Unit, Hematology Center, Karolinska University Hospital and Ka Karolinska aro roli l nsska IInstitute, li n ti ns titu tute tu te Stockholm, Sweden; 2Dept of Medicine, Soonchunhyang University Gumi’s Hospital, North Kyungsang Province, South Korea; 3McMaster University, Population Health Research Institute, Institute Hami Ha Hamilton, milt mi lton lt on, ON on ON,, Canada; 4Lankenau Medical all C Center, enter, Thomas Jeffe Jefferson feers rson o Medical College, Wynn Wy nnew woo od, P A; 5Up Uppsala Upps psal a a Clinical Clin Cl inic icall Research Res esea e rc rchh Center Ce r and and Dept Dep ep pt of of Medical Med edical al Sciences, Scie Sc ienc n es es,, Up Upps Uppsala sal ala Wynnewood, PA; University, Un Universi ity ty,, Uppsala, Uppsal Upp psal ala, a, Sweden; Swede wede den; n; Bo Boehringer Boeh e ring eh ri ger IIngelheim nggellheim im P Pharma harm rmaa Gm Gmb GmbH bH & C bH Co o KG KG, In Ingelheim, nge g lh lhei eim ei m, Germany; Germany; 7Facu Faculty culty off Medicine cu Meedicine ic Ma Mann Mannheim, nnnheim m, Un University niv verssitty of of H Heidelberg, eiideelberrg,, Mannheim, Man nnheiim, m, Germany; Gerrmaany y; Dept De pt ooff Me Med Medicine, dici cinne, Mc M McMaster Mast Ma s err U st University nivvers versiity ity aand nd dT Thrombosis hrrom mbo osis and and At A Atherosclerosis herosscle hero scleero rosi siis Research Re ear Rese arch ch h Inst In Institute, stit itut utte, e, H Hamilton, amil am ilto tonn, O to ON, N, C N, Canada anad an adaa Ad Add dress for for Correspondence: Correspondence: d Address Sam Schulman, MD Thrombosis Service HHS-General Hospital 237 Barton Street East Hamilton, ON, L8L 2X2 Canada Tel: 1-905-5270271, ext 44479 Fax: 1-905-5270271 E-mail: schulms@mcmaster.ca Journal Subject Codes: Anticoagulants:[184] Coumarins, Anticoagulants:[185] Other anticoagulants, Etiology:[5] Arrhythmias, clinical electrophysiology, drugs, Thrombosis:[173] Deep vein thrombosis Downloaded from http://circ.ahajournals.org/ by guest on April 27, 2014 DOI: 10.1161/CIRCULATIONAHA.113.002332 Abstract: BackgroundThe aim of this study was to compare the management and prognosis of major bleeding in patients treated with dabigatran or warfarin Methods and ResultsTwo independent investigators reviewed bleeding reports from 1,034 individuals with 1,121 major bleeds enrolled in phase III trials comparing dabigatran with warfarin in 27,419 patients treated for to 36 months Patients with major bleeds on dabigatran (n=627 of 16,755) were older, had lower creatinine clearance and more frequently used aspirin or non-steroid anti-inflammatory agents than those on warfarin (n=407 of 10,002) The 30-day mortality after the first major bleed tended to be lower in the dabigatran group (9.1%) than in the warfarin group (13.0%; pooled odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.46-1.01; pp=0.057) 0.057) After adjustment for sex, age, weight, renal function and concomitant antithrombotic ant ntit ithr hrom ombo boti tic herapy, the pooled OR for 30-day mortality with dabigatran versus warfarin was waas 0.66 66 (95% (95 95% % CI: CI therapy, 0.44-1.00; p=0.051) Major bleeds in dabigatran patients were more frequently treated with blood ransf sfus usio ionss ((423/696, 423/ 3/69 3/ 696, 61%) than bleeds in warf far arin in patients (175/425 5, 42 42%; p
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